SPREADER

GUDID G426SI10010

SPREADER

STONE INSTRUMENTS CO

Orthopaedic surgical distractor, internal

• Primary Device ID: G426SI10010
• NIH Device Record Key: f1b0f264-ab03-4dd5-9a2c-1af6eb808cdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPREADER
• Version Model Number: SI-1001
• Company DUNS: 645446428
• Company Name: STONE INSTRUMENTS CO
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G426SI10010 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

[G426SI10010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-17
• Device Publish Date: 2023-03-09

Devices Manufactured by STONE INSTRUMENTS CO

• G426STNKLTR0614240 - PLATE HOLDING FORCEPS: 2024-08-28 FORCEPS, HOLDING, PLATE, CMF, AO ANGLED, TOUCHING W/1 BALLS, 15 CM
• G426KLTR032223PF0 - PLATE HOLDING FORCEPS: 2023-05-08 LEVEL ONE, FORCEPS, HOLDING, PLATE, AO STYLE, TOUCHING W/1 BALLS, 15 CM
• G426KLTR032223V010 - PLATE HOLDING FORCEPS: 2023-05-08 LEVEL ONE, FORCEPS, HOLDING, PLATE, RIB, MANGLA, RIGHT ANGLE, 20 CM, QTY: 001 EA
• G426SI10010 - SPREADER: 2023-03-17SPREADER
• G426SI10010 - SPREADER: 2023-03-17 SPREADER
• G426SI10060 - COMPRESSOR: 2023-03-17 COMPRESSOR
• G426SI10230 - ROD HOLDER: 2023-03-17 ROD HOLDER USED TO HOLD ROD IN SPINE SURGERY
• G426SI1023CA0 - ROD HOLDER: 2023-03-17 ROD HOLDER COMPOUND ACTION
• G426SI10380 - ROD CUTTER: 2023-03-17 ROD CUTTER EXTRA LONG, CUT MULTIPLE RODS SIZES